mdi ConsultantsThe FDA new user fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows:
FY16 User Fees (in U.S. Dollars)
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| 510(k)‡ | $5,228 | $2,614 |
| 513(g) | $3,529 | $1,765 |
| PMA, PDP, PMR, BLA | $261,388 | $65,347 |
| panel-track supplement | $196,041 | $49,010 |
| 180-day supplement | $39,208 | $9,802 |
| real-time supplement | $18,297 | $4,574 |
| BLA efficacy supplement | $261,388 | $65,347 |
| PMA annual report | $9,149 | $2,287 |
| 30-day notice | $4,182 | $2,091 |
‡ for small businesses with an approved SBD.
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Annual Establishment Registration Fee: $3,845
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
? Any questions email us at [email protected] and ref: FDA user fees